Placing sutures

ABSTRACT

A suturing instrument is configured for to apply sutures to approximate, ligate, or fixate tissue in, for example, open, mini-incision, trans-vaginal, or endoscopic surgical procedures. The suturing instrument includes an elongate body member, a needle exit port, a needle receiving port, and a needle deployment mechanism. The suturing instrument eliminates the need for a preassembled needle and suture and reduces or eliminates the possibility of needle loss during suturing.

TECHNICAL FIELD

[0001] The invention relates to devices and methods for placing sutures.

BACKGROUND INFORMATION

[0002] Suturing of body tissue is a time consuming aspect of manysurgical procedures. For many surgical procedures, it is necessary tomake a large opening in the human body to expose the area that requiressurgical repair. There are instruments available that allow for viewingof certain areas of the human body through a small puncture woundwithout exposing the entire body cavity. These instruments, calledendoscopes, can be used in conjunction with specialized surgicalinstruments to detect, diagnose, and repair areas of the body thatpreviously required open surgery to access.

[0003] Some surgical instruments used in endoscopic procedures arelimited by the manner in which they access the areas of the human bodyin need of repair. In particular, the instruments may not be able toaccess tissue or organs located deep within the body or that are in someway obstructed. In addition, many of the instruments are limited by theway they grasp tissue, apply a suture, or recapture the needle andsuture. Furthermore, many of the instruments are complicated andexpensive to use due to the numerous parts and/or subassemblies requiredto make them function properly. Suturing remains a delicate andtime-consuming aspect of most surgeries, including those performedendoscopically.

SUMMARY OF THE INVENTION

[0004] The invention generally relates to a medical device forperforming a surgical procedure, such as passing a suture throughtissue. Specifically, the invention relates to a suturing instrumentthat eliminates the need for a preassembled needle and suture andreduces or eliminates the possibility of needle loss during suturing.The suturing instrument is configured to apply sutures to approximate,ligate, or fixate tissue in, for example, open, mini-incision,trans-vaginal, or endoscopic surgical procedures.

[0005] The suturing instrument uses a needle housed within an elongatebody member. The needle has a sharpened tip for tissue penetration and ahook-shaped distal portion for capturing a suture. When the suturinginstrument is actuated, the needle is advanced out of the elongate bodyof the suturing instrument through tissue and into a second opening inthe suturing instrument. The needle captures a suture held within thesecond opening of the suturing instrument in the hook-shaped distalportion of the needle. The needle is then retracted back through thetissue carrying the suture through the tissue. Alternatively, the needlecan travel about the tissue, as opposed to through the tissue, therebycarrying the suture back around the tissue to ligate a vessel, forexample. The suturing instrument can then be removed from the bodyleaving the suture intact.

[0006] In one aspect, the invention is directed to a suturing instrumentincluding an elongate body member including a distal portion defining afirst opening and a second opening opposing the first opening, a needle,and a needle deployment mechanism. The needle is at least partiallydisposed within the elongate body member and includes a hook-shapeddistal portion and a tissue-penetrating tip distal of the hook-shapeddistal portion. The needle deployment mechanism is coupled to a proximalportion of the needle and disposed at least partially within theelongate body member. The needle deployment mechanism moves the needlebetween the first and second openings. In one embodiment, the needleincludes a latch movable between a first position in which thehook-shaped distal portion is open and a second position in which thehook-shaped distal portion is closed.

[0007] In another aspect, the invention relates to a suturing instrumentincluding an elongate body member including a distal portion defining afirst opening and a second opening that opposes the first opening, aneedle at least partially disposed within the elongate body member, anda needle deployment mechanism coupled to a proximal portion of theneedle and disposed at least partially within the elongate body memberfor moving the needle between the first and second openings. The needleincludes means for penetrating tissue and means for capturing andpulling a suture from the second opening.

[0008] In yet another aspect, the invention relates to a suturinginstrument including an elongate body member including a distal portiondefining a first opening and a second opening that opposes the firstopening, a needle at least partially disposed within the elongate bodymember, and a needle deployment mechanism coupled to a proximal portionof the needle and disposed at least partially within the elongate bodymember for moving the needle between the first and second openings. Theneedle includes a hook-shaped distal portion for pulling a suture fromthe second opening and a tissue-penetrating tip distal of thehook-shaped distal portion. In one embodiment, the needle includes alatch movable between a first position in which the hook-shaped distalportion opens as the needle exits the first opening and a secondposition in which the hook-shaped distal portion closes as the needleexits the second opening with the suture, thereby capturing the suturein the hook-shaped distal portion of the needle.

[0009] In various embodiments of the foregoing aspects of the invention,the body member includes a protuberance disposed on an internal surfaceof the first opening. The protuberance acts to open the hook-shapeddistal portion of the needle by moving the latch to the first position.The body member can include a protuberance disposed on an internalsurface of the second opening. The protuberance acts to close thehook-shaped distal portion of the needle by moving the latch to thesecond position. The body member can also include a flexible tubularmember disposed distal of the protuberance. The flexible tubular memberholds a suture in place. In one embodiment, the flexible tubular memberis a spring. The flexible tubular member can define a first lumen andthe distal portion of the suturing instrument can define a second lumengenerally axially aligned with the first lumen. In addition, the distalportion of the suturing instrument can include a slot in communicationwith the first lumen and the second lumen.

[0010] In some embodiments of the suturing instrument, the latch ispivotably coupled to the needle, in others the latch is slidablydisposed on the needle. In one embodiment, the distal portion of thesuturing instrument has a generally C-shaped or circular profile thatdefines an opening for receiving tissue. The needle can be substantiallystraight or curved. Where the needle is curved, the latch can bedisposed on an inside diameter of the needle or an outside diameter ofthe needle. In additional embodiments, the elongate body member caninclude one or more bends. The suturing instrument can be adapted toaccess remote organs or tissue within a body. The distal portion of theelongate body member may be rotatable relative to the remainder of theelongate body member. Further, the suturing instrument can include ahandle disposed opposite the distal portion of the elongate body member.The handle can at least partially house the needle deployment mechanism.The suturing instrument can also include a suture disposed in the secondopening.

[0011] These and other objects, along with advantages and features ofthe present invention herein disclosed, will become apparent throughreference to the following description, the accompanying drawings, andthe claims. Furthermore, it is to be understood that the features of thevarious embodiments described herein are not mutually exclusive and canexist in various combinations and permutations.

BRIEF DESCRIPTION OF THE DRAWINGS

[0012] In the drawings, like reference characters generally refer to thesame parts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis instead generally being placed uponillustrating the principles of the invention. In the followingdescription, various embodiments of the present invention are describedwith reference to the following drawings, in which:

[0013]FIG. 1A is a schematic plan view of one embodiment of a suturinginstrument in accordance with the invention;

[0014]FIGS. 1B and 1C are schematic cross-sectional views of theproximal and distal portions of the suturing instrument of FIG. 1A;

[0015]FIG. 1D is a schematic cross-sectional view of an alternativeembodiment of the suturing instrument of FIG. 1A;

[0016] FIGS. 2A-2B, 2D-2E, and 2G-2H are enlarged cross-sectional sideviews of the distal portion of the suturing instrument of FIG. 1A invarious operational phases;

[0017]FIGS. 2C, 2F, and 2I are enlarged schematic top views of thedistal portion of the suturing instrument of FIG. 1A in variousoperational phases;

[0018]FIG. 3A is an enlarged cross-sectional side view of the distalportion of an alternative suturing instrument in accordance with theinvention;

[0019]FIG. 3B is an enlarged top view of the distal portion of thesuturing instrument of FIG. 3A;

[0020] FIGS. 4A-4C are schematic representations of an alternativeembodiment of a suturing instrument in accordance with the invention, asused in various applications;

[0021] FIGS. 5A-5F are schematic representations of the method of usingthe suturing instrument of FIG. 4B;

[0022] FIGS. 6A-6I are schematic representations of the method of usingthe suturing instrument of FIG. 4C to place additional stitches;

[0023] FIGS. 7A-7C are schematic side views of alternative needleembodiments; and

[0024] FIGS. 8A-8F are schematic perspective views of anotheralternative needle embodiment.

DESCRIPTION

[0025] Embodiments of the present invention are described below. It is,however, expressly noted that the present invention is not limited tothese embodiments, but rather the intention is that variations,modifications, and equivalents that are apparent to the person skilledin the art are also included.

[0026] A suturing instrument according to the invention can be used, forexample, to access areas within the human body to ligate, fixate, orapproximate tissue. The suturing instrument can throw one or morestitches intercorporeally. FIG. 1A illustrates the general structure ofone embodiment of the present invention. FIG. 1A depicts a suturinginstrument 100 including a handle 102, an elongate body member 104, anda needle deployment mechanism 110. The suturing instrument 100 has adistal portion 106 and a proximal portion 108. The elongate body member104 is mechanically coupled to the handle 102 at the proximal portion108 and the suturing components are housed in the distal portion 106 ofthe suturing instrument 100.

[0027] The handle 102 could take a variety of forms, for example, thehandle 102 could be one of the types used with Boston ScientificCorporation suturing systems, in particular the Capio® Push & Catchsuturing system. Generally, the needle deployment mechanism 110 extendslongitudinally through the elongate body member 104 to the distalportion 106 of the suturing instrument 100, where the needle deploymentmechanism 110 is coupled to a needle. The needle deployment mechanism110 moves the needle between a retracted position and a deployedposition. One example of the needle deployment mechanism 110 is shown ingreater detail in FIGS. 1B and 1C.

[0028]FIGS. 1B and 1C are cross-sectional views of the proximal portion108 of the suturing instrument 100 (FIG. 1B) and the distal portion 106of the suturing instrument 100 (FIG. 1C). FIG. 1B depicts the suturinginstrument 100 including the handle 102, the elongate body member 104,and the needle deployment mechanism 110. The needle deployment mechanism110 includes a button 117, a shaft 116, a bearing 118, a button end 119,and a hole 121. The bearing 118 rides along a cylindrical surface 105that is formed by the inside diameter of the elongate body member 104. Awireform 103 is inserted into the hole 121, coupling it to the actuatorbutton 117. A spring 115 encircles the wireform 103, abuts the buttonend 119, and is compressed between the button end 119 and a springwasher 113. The spring washer 113 is seated upon a center tube 107. Thecenter tube 107 is housed by the cylindrical surface 105 and isconstrained at the distal portion 106. A pusher wire 111 is attached tothe wireform 103 by means of a weld, a coupling, adhesive or other meansand is slidably disposed within a guidance sleeve 109, the sleeve 109being disposed within a cylindrical surface 123 formed by the insidediameter of the center tube 107. In one embodiment, the pusher wire 111is constructed of nitinol. Nitinol is a nickel-titanium alloy so chosenfor its combination of properties that allow for bendability and highcolumn strength when constrained.

[0029]FIG. 1C is a detailed cross-sectional view of the distal portion106 of the suturing instrument 100. The pusher wire 111 is attached bywelding or other means to a coupling 150, which is slidably disposedwithin a track 152. The coupling 150 is attached to a carrier wire 154,which by virtue of its attachment to the coupling 150 is also slidablydisposed within the track 152. The carrier wire 154 is mechanicallycoupled to the needle 124 by means of a weld, a coupling, adhesive, orother means. The coupling 150 abuts a backstop washer 156 that isslidably disposed about the pusher wire 111 and is contained within apocket 160 that includes a back wall 162, against which the backstopwasher 156 rests. The track 152 terminates distally in a pocket 164 thatincludes a wall 166. A downstop washer 158 is slidably disposed aboutthe carrier wire 154 and constrained within the pocket 164.

[0030] In operation, the needle deployment mechanism 110 is actuated bypushing on the button 117, which via the attachment to the wireform 103which is attached to the pusher wire 111, moves the coupling 150 alongthe track 152 concomitantly moving the carrier wire 154, which slidablymoves the needle 124, thereby driving the needle 124 through tissue. Asthe pusher wire 111 responds to greater urging of the button 117, thecoupling 150 reaches a point in its travel along the track 152 where itpushes the downstop washer 158 such that it abuts the wall 166 of thepocket 164. This action limits the outward travel of the carrier wire154 to prevent overdriving and eliminate the possibility of expellingthe needle 124 from the suturing instrument 100. As the button 117 isreleased, the spring 115 urges the button 117 proximally, moving thepusher wire 111, the coupling 150, and the carrier wire 154 proximallyalong with the button 117 to the retracted position.

[0031] In an alternative needle deployment mechanism 1010 (FIG. 1D), thebutton 1012 operates a drive screw 1025 and a compression spring 1030,which are housed in the proximal portion 1008 of the body 1004. Thebutton 1012 is mechanically linked to the drive shaft 1035, which movesa gear drive 1040, which in turn drives a gear 1045. The gear 1045 iscoupled to a link drive pin 1050, which is itself coupled to a needlepusher 1055. The needle pusher 1055 is in turn coupled to a needle 1024.The pusher 1055 advances the needle 1024 out of a needle exit port 1020and into a needle receiving port 1022. The spring 1030 acts to retractthe needle 1024 from the needle receiving port 1022 once the button 1012is released.

[0032] In some embodiments, the suturing instrument 100 may include anoptional articulation 114 disposed in the elongate body member 104proximate the distal portion 106 (FIG. 1A). The articulation 114facilitates the rotation and positioning of the distal portion 106 ofthe suturing instrument 100. In addition, the elongate body 104 can besubstantially straight or may include one or more bends. Thearticulation 114 and/or bend(s) can facilitate access to deep and/ordifficult to reach areas within the human body.

[0033] The suturing instrument's component materials should bebiocompatable. For example, the handle 102, the elongate body member104, and portions of the needle deployment mechanism may be fabricatedfrom extruded, molded, or machined plastic material(s), such aspolypropylene, polycarbonate, or glass-filled polycarbonate. Othercomponents, for example the needle 124, may be made of stainless steel.Other suitable materials will be apparent to those skilled in the art.The type of material(s) used to form the suture is not critical to thepresent invention, as long as the material is biocompatible. The surgeonwill select the length, diameter, and characteristics of the suture tosuit a particular application. Additionally, the mechanical componentsand operation are similar in nature to those disclosed in U.S. Pat. Nos.5,364,408 and 6,048,351, the disclosures of which are herebyincorporated herein by reference in their entireties.

[0034] FIGS. 2A-2I depict enlarged views of the distal portion 106 ofthe suturing instrument 100 and the suturing components during variousphases of operation. FIG. 2A is an enlarged cross-sectional view of thedistal portion 106 and depicts an elongate needle 124, a first openingor “needle exit port” 120, and a second opening or “needle receivingport” 122. The distal portion 106 has an essentially C-shaped profile;however, the profile can vary to suit a particular application, as longas the needle exit port 120 and the needle receiving port 122 aregenerally in opposition. In many instances, the open area 131 defined bythe C-shaped profile receives the tissue to be sutured. The needle 124includes a hook-shaped distal portion 126, a tip 130 disposed distallytherefrom, and an optional latch 128. The tip 130 is configured topenetrate tissue and has an essentially conical shape; however, theshape can vary to suit a particular application and may include cuttingedges. The hook-shaped distal portion 126 is disposed in a side of theneedle 124 and the size and shape of the hook shape can be chosen tosuit a particular application. Examples of different needles andhook-shaped distal portions are illustrated in FIGS. 7A-7C and 8A-8F.The latch 128 is pivotably coupled to the needle 124 and opens thehook-shaped distal portion 126 in a first position and closes thehook-shaped distal portion 126 in a second position. In the embodimentshown, the latch 128 is coupled to the needle 124 via a hinge 129. Inthe first position, the latch 128 is pivoted back over the body of theneedle 124, thereby opening the hook-shaped distal portion 126. In analternative embodiment, the latch 128 is slidably coupled to the needle124. The needle exit port 120 includes a latch opener 132 disposedtherein for actuating the latch 128. The needle receiving port 122includes a latch closer 134 disposed therein for actuating the latch 128and a suture holder 136 disposed distally from the latch closer 134.

[0035] In FIG. 2A, the suturing instrument 100 is shown in a startingposition with the needle 124 positioned within the needle exit port 120proximal of the latch opener 132. In FIG. 2B, the needle 124 is advancedpartially out of the needle exit port 120. As the needle 124 passes thelatch opener 132, a leading edge 133 of the latch 128 contacts the latchopener 132, thereby pivoting the latch 128 up and opening thehook-shaped distal portion 126. Specifically, the latch 128 is caughtand lifted by the latch opener 132. In one embodiment, the latch opener132 extends the entire width of the needle exit port 120. As the needle124 continues this forward movement, the latch 128 pivots at the hinge129 approximately 180 degrees. The hook-shaped distal portion 126 is nowcompletely open. The needle exit port 120 includes an open area 125above the needle 124 that serves as clearance for the latch 128 as itpivots open. The needle 124 is free to continue past the latch opener132, because the latch 128 can be either slightly recessed in the bodyof the needle 124 in the open position or the latch opener 132 can flexor rotate out of the path of the now open latch 128.

[0036] In FIG. 2C, the needle 124 is advanced approximately 50% of itsfull range. The latch 128 is pivoted back over the needle 124 and thehook-shaped distal portion 126 is fully exposed. While advancing theneedle 124 through tissue, the tissue may prolapse into the hook-shapeddistal portion 126; however, because the trailing edge 143 (FIG. 2A) ofthe hook-shaped distal portion 126 has no sharp edges, as shown in thisembodiment, the tissue does not catch in the hook-shaped distal portion126. In opposition to the needle exit port 120 is the needle receivingport 122. The needle receiving port 122 includes a latch closer 134disposed on an interior wall thereof and extending approximately 50% ofthe width of the needle receiving port 122. The needle receiving port122 also includes a suture holder 136 that extends approximately 50% ofthe width of the needle receiving port 122. The suture holder 136 is agenerally flexible elongate member defining a lumen 138 extendingtherethrough (FIG. 2A). In the embodiment shown, the suture holder 136is a spring; however, other flexible tubular structures may be used, forexample, a nitinol tube. In operation, the suture holder 136 has one ormore sutures 140 threaded through the lumen 138. Further, the suture 140runs through a second lumen 139 disposed within the distal portion 106of the suturing instrument 100 and generally axially aligned with thelumen 138 in the suture holder 136, thereby forming a suture bridgeacross the width of the needle receiving port 122. Typically, the suture140 is threaded through the suture holder 136 and the second lumen 139and the ends of the suture 140 are secured at or about the proximalportion 108 of the suturing instrument 100.

[0037]FIG. 2D depicts the needle 124 entering the funnel-shaped openingof the needle receiving port 122. The needle 124 advances past the latchcloser 134 and contacts the suture holder 136. The suture holder 136flexes in response to the force of the advancing needle 124 and isdeflected upward to allow the needle tip 130 to pass the suture holder136. The suture holder 136 helps to protect the suture 140 as the needle124 passes. As can be seen in FIG. 2E, the suture holder 136 flexes backto its original position after the needle tip 130 advances past thesuture holder 136 and the suture holder 136 and suture 140 drop into thehook-shaped distal portion 126. In this position, the suture 140 iscaptured within the hook-shaped distal portion 126 (FIG. 2F). As can beseen in FIG. 2F, the suture holder 136 extends past the centerline 145of the needle receiving port 122; however, in other embodiments, thesuture holder 136 extends about or less than the distance to thecenterline 145.

[0038] In FIG. 2G, the needle 124 is partially retracted from the needlereceiving port 122. The needle 124 flexes the suture holder 136 out ofthe hook-shaped distal portion 126, but holds onto the suture 140 as theneedle 124 moves past the suture holder 136. At approximately the sametime, the leading edge 133 of the latch 128 engages the latch closer 134and begins pivoting back to the closed position over the hook-shapeddistal portion 126. As the needle 124 continues to retract out of theneedle receiving port 122 (FIGS. 2H and 2I), the latch 128 is fullypivoted to the second (or closed) position to capture the suture 140within the hook-shaped distal portion 126. The needle receiving port 122includes an open area 127 above the needle 124 that acts as clearancefor the latch 128 as it pivots to the closed position. In addition tosecuring the suture 140 within the hook-shaped distal portion 126, theclosed latch 128 prevents tissue from prolapsing into the hook-shapeddistal portion 126, where it may become caught and/or torn by thehook-shaped distal portion 126; however, in embodiments without a latch128, the size and shape of the hook-shaped distal portion 126 can bechosen to reduce or eliminate the possibility of tissue damage whenretracting the needle 124.

[0039] As shown in FIGS. 2H and 2I, the needle 124 is retracted throughthe open area 131 (and tissue if the device is so positioned) pullingthe suture 140 through the open area 131 and/or tissue. After the needle124 is fully retracted into the needle exit port 120, the suturinginstrument 100 can be removed and the suture 140 retrieved and secured.The suture 140 can be knotted internally or externally to the body.Also, the suturing instrument may include a knot pusher 146 disposed onits distal portion 106 to help position the knot relative to the tissue.Alternatively, the needle 124 can be advanced again to capture a secondsuture.

[0040]FIGS. 3A and 3B depict an alternative embodiment of a suturinginstrument 200 in accordance with the invention. The operation of thesuturing instrument 200 is similar to that described with respect toFIGS. 2A-2I, but with several differences. The latch 228 is slidablydisposed on the needle 224, as opposed to pivotably coupled to theneedle 224. As the needle 224 advances out of the needle exit port 220,a leading edge 233 of the latch 228 engages a latch opener 232 disposedwithin the needle exit port 220. The latch opener 232 slides the latch228 rearward into a first (or open) position, thereby exposing thehook-shaped distal portion 226. Once the latch 228 reaches the full openposition, the needle 224 advances past the latch opener 232 by, forexample, flexing the latch opener 232 out of alignment with the leadingedge 233 of the latch 228.

[0041] The needle receiving port 222 includes a latch closer 234 and asuture holder 236. The latch closer 234 is a protuberance integrallyformed with the opening of the needle receiving port 222 (FIG. 3B). Thesmooth contour of the latch closer 234 allows for easier passage of thesuture 240 out of the needle receiving port 222. The suture holder 236is a flexible tube, such as a nitinol tube. The distal portion 206 ofthe suturing instrument 200 includes a slot 244 vertically aligned withthe suture holder 236. The suture holder 136 includes a slot 245 alignedwith the slot 244 in the distal portion 206 of the instrument 200. Theslots 244, 245 facilitate loading one or more sutures 240 into thesuture holder 236 by just dropping the suture 240 into the slots 244,245. As discussed hereinabove with respect to FIGS. 2D and 2E, thesuture holder 236 flexes in response to the advancing needle 224,thereby allowing the needle 224 to capture the suture 240.

[0042] FIGS. 4A-4C depict various suturing procedures that can beperformed with the suturing instrument 100 described hereinabove or analternative embodiment of a suturing instrument 400 in accordance withthe invention. The alternative embodiment of the suturing instrument 400is similar in structure and operation to the suturing instrument 100described hereinabove. The suturing instrument 400 includes a generallycircular distal portion 406, which houses a curved needle 424. Otherthan the shape, the structure and operation of the needle 424 aresimilar to that described hereinabove. The hook-shaped distal portion426 and latch 428 may be located on either the inside diameter or theoutside diameter of the needle 424. The position of the latch opener 432and the latch closer 434 within their respective ports will be adjustedas necessary to engage the latch 428. Alternatively, the needle 424 maynot include a latch. The suturing instrument 400 depicted in FIGS. 4A-4Calso differs from the previously described suturing instrument 100 withrespect to the travel direction of the needle 424, 124. Needle 124travels away from the proximal portion 108 of the suturing instrument100 and needle 424 travels towards the proximal portion 408 of thesuturing instrument 400.

[0043] In FIG. 4A, the suturing instrument 400 is being used to performligation, which is a procedure where a vessel, such as an artery, isclosed off. The vessel 405 is positioned within the circular distalportion 406 of the instrument 400. The needle 424 is advanced out of theneedle exit port 420, enters the needle receiving port 422, and isretracted back to the needle exit port 420 with the suture 440 capturedwithin the hook-shaped distal portion 426. The instrument 400 can thenbe withdrawn leaving a length of suture 440 around the vessel 405, whichcan subsequently be tied off, thereby closing the vessel 405. In thisprocedure, the needle 424 carries the suture 440 around the vessel 405,but does not penetrate the vessel 405.

[0044] In FIG. 4B, the instrument 400 is being used to place a suture440 through a single piece of tissue 415. As seen in greater detail inFIGS. 5A-5F, the needle 424 is driven through the tissue 415 until theneedle 424 captures the suture 440 held within the needle receiving port422 (FIGS. 5A-5C), as described above. Subsequently, the needle 424 isretracted back to the needle exit port 420, thereby pulling the suture440 through the tissue 415 (FIGS. 5D and 5E). The needle 424 actuallypulls a loop of suture 440 through the tissue 415, which results in twolengths of suture 440 through a common passage in the tissue 415. Theinstrument 400 can then be withdrawn leaving the two lengths of suture440 through the tissue 415 (FIG. 5F), which subsequently can be securedto another structure.

[0045] In FIG. 4C, the instrument 400 is being used to approximate twopieces of tissue 425. The needle 424 is driven through the two pieces oftissue 425 until the needle 424 captures the suture 440 held within theneedle receiving port 422. Subsequently, the needle 424 is retractedback to the needle exit port 420, thereby pulling the suture 440 throughthe tissue 425. The instrument 400 can then be withdrawn leaving alength of suture 440 through the tissue 425, which subsequently can betied off to complete the approximation. In each preceding example, theneedle 424 can be advanced a second time to pull an additional twolengths of suture 140 through or around the tissue 405, 410, 425.

[0046] FIGS. 6A-6I depict the suturing instrument 400 of FIG. 4C beingused to pass a second length of suture 440 through the tissue 425. FIGS.6A-6C and 6F-6I are enlarged side views of the distal portion 406 of thesuturing instrument 400, and FIGS. 6D and 6E are top views of thesuturing instrument 400 shown in FIGS. 6B and 6D, respectively. In FIG.6A, the suturing instrument 400 is moved to a position adjacent thetissue 425 that is offset from the first suture pass. In FIGS. 6B and6C, the needle 424 is advanced through the tissue 425 until the needle424 captures the suture 440 held within the suture holder 436 disposedwithin the needle receiving port 422. As can be seen in FIG. 6B, thesuture is released from the hook-shaped distal portion 426 as the needle424 is advanced and the latch 428 is opened. The needle 424 passesthrough a loop 441 in the suture 440 that was pulled through the tissue425 by the first pass of the needle 424. In the embodiment shown, thehook-shaped distal portion 426 and latch 428 are disposed on the outsidediameter of the needle 424.

[0047] In FIG. 6D, the suture 440 is shown pulled from the needlereceiving port 422. This length of suture 440 was pulled out during thefirst pass of the needle 424. As the needle 424 re-enters the needlereceiving port 422 (FIG. 6E), the suture 440 is pushed aside by theneedle 424 and the needle 424 deflects the suture holder 436 up and theninto the hook-shaped distal portion 426, as discussed hereinabove withrespect to FIGS. 2A-2I. As shown in FIGS. 6F-6H, the needle 424 isretracted from the needle receiving port 422 pulling another loop ofsuture 440 through the tissue 425. The second loop of suture 440 ends upwithin the first loop 441 (FIG. 6G). After the needle 424 is fullyretracted into the needle exit port 420, the suturing instrument 400 canbe removed (FIG. 6I) and the suture 440 retrieved and secured. Thesuture 440 can be knotted internally or externally to the body.

[0048] FIGS. 7A-7C depict various embodiments of needles that can beused in a suturing instrument in accordance with the invention. In FIG.7A, the needle 724 is generally elongate and linear in shape andincludes a proximal portion 740 and a hook-shaped distal portion 726.The diameter 744 of the hook-shaped distal portion 726 is smaller thanthe diameter 742 of the body of the needle 724. This reduction indiameter helps to prevent tissue from prolapsing into the hook-shapeddistal portion 726 when retracting the needle 724 without a latch. InFIG. 7B, the needle 824 is generally curved and includes a proximalportion 840 and a hook-shaped distal portion 826. The hook-shaped distalportion 826 is oriented on the inside diameter 810 of the needle 824.The needle 924 shown in FIG. 7C is substantially the same as needle 824,except the hook-shaped distal portion 924 is oriented on the outsidediameter 910 of the needle 924. In each of these embodiments, theproximal portion 740, 840, 940 can be mechanically coupled to the needledeployment mechanism 110.

[0049] FIGS. 8A-8F depict another embodiment of a needle that can beused in a suturing instrument in accordance with the invention. Theneedle 942 is generally elongate and linear in shape and includes a bodyportion 950, a proximal tube portion 944, a hook-shaped distal portion960 including a needle tip 948, and a latch 946. The proximal tubeportion 944 includes a first stop edge 952 and the hook-shaped distalportion 960 includes a second stop edge 956 (FIG. 8B). The latch 946includes a proximal edge 954 and a distal edge 964 and is slidablydisposed about the body portion 950 to selectively expose (open) andcover (close) at least a portion of the hook-shaped distal portion 960.

[0050] In operation, as a user pushes the needle 942 through a patient'stissue (by methods previously described), friction between the needle942 and the tissue causes the latch 946 to slide over the body portion950 in a direction indicated by arrow 958 until the proximal edge 954contacts the first stop edge 952 (FIG. 8C). This results in thehook-shaped distal portion 960 being at least partially opened tocapture a suture 968 (FIG. 8D). After the hook-shaped distal portion 960captures the suture 968, the user retracts the needle 942 (by methodspreviously described). As the user retracts the needle 942, frictionbetween the needle 942 and the tissue causes the latch 946 to slide overthe body portion 950 in a direction indicated by arrow 962 until theproximal edge 954 contacts the second stop edge 956 (FIGS. 8E and 8F).This results in the hook-shaped distal portion 960 being at leastpartially closed by the latch 946. Covering the hook-shaped distalportion 960 with latch 946 helps to prevent tissue from prolapsing intothe hook-shaped distal portion 960 when the user retracts the needle942. Alternatively, the latch 946 can be opened and closed by contactinga latch opener and a latch closer as previously described and shown inFIGS. 2A-2I. The latch 946 has an outside diameter that is greater thanany other outside diameter of the needle 942. As a result, only thelatch 946 contacts the latch opener or latch closer when the needle 942is advanced or retracted.

[0051] Other embodiments incorporating the concepts disclosed herein maybe used without departing from the spirit and scope of the invention.The described embodiments are to be considered in all respects as onlyillustrative and not restrictive.

What is claimed is:
 1. A suturing instrument comprising: an elongatebody member including a distal portion defining a first opening and asecond opening that opposes the first opening; a needle at leastpartially disposed within the elongate body member, the needle includinga hook-shaped distal portion and a tissue-penetrating tip distal of thehook-shaped distal portion; and a needle deployment mechanism coupled toa proximal portion of the needle and disposed at least partially withinthe elongate body member for moving the needle between the first andsecond openings.
 2. The suturing instrument of claim 1 wherein theneedle further comprises a latch movable between a first position inwhich the hook-shaped distal portion is open and a second position inwhich the hook-shaped distal portion is closed.
 3. The suturinginstrument of claim 2 wherein the body member comprises a protuberancedisposed on an internal surface of the first opening for moving thelatch to the first position when the needle is moved from the firstopening to the second opening.
 4. The suturing instrument of claim 2wherein the body member comprises: a protuberance disposed on aninternal surface of the second opening for moving the latch to thesecond position when the needle is moved from the second opening to thefirst opening; and a flexible tubular member for holding a suture, theflexible tubular member disposed within the second opening and distal ofthe protuberance.
 5. The suturing instrument of claim 2 wherein thelatch is pivotably coupled to the needle.
 6. The suturing instrument ofclaim 2 wherein the latch is slidably disposed on the needle.
 7. Thesuturing instrument of claim 1 wherein the needle is substantiallystraight.
 8. The suturing instrument of claim 1 wherein the needle iscurved.
 9. The suturing instrument of claim 4 wherein the flexibletubular member comprises a spring.
 10. The suturing instrument of claim4 wherein the flexible tubular member defines a first lumen and thedistal portion of the suturing instrument defines a second lumengenerally axially aligned with the first lumen.
 11. The suturinginstrument of claim 10 further comprising a slot defined by the distalportion of the suturing instrument, the slot in communication with thefirst lumen and the second lumen.
 12. The suturing instrument of claim 1further comprising a suture disposed within the second opening.
 13. Thesuturing instrument of claim 1 wherein the elongate body member includesa bend
 14. The suturing instrument of claim 1 wherein the elongate bodymember includes two bends.
 15. The suturing instrument of claim 1further comprising a handle disposed opposite the distal portion of theelongate body member, the handle at least partially houses the needledeployment mechanism.
 16. The suturing instrument of claim 1 wherein thedistal portion of the elongate body member can rotate relative to aremainder of the elongate body member.
 17. A suturing instrumentcomprising: an elongate body member including a distal portion defininga first opening and a second opening that opposes the first opening; aneedle at least partially disposed within the elongate body member, theneedle comprising means for penetrating tissue and means for capturingand pulling a suture from the second opening; and a needle deploymentmechanism coupled to a proximal portion of the needle and disposed atleast partially within the elongate body member for moving the needlebetween the first and second openings.
 18. A suturing instrumentcomprising: an elongate body member including a distal portion defininga first opening and a second opening that opposes the first opening; aneedle at least partially disposed within the elongate body member, theneedle comprising: a hook-shaped distal portion for capturing andpulling a suture from the second opening; and a tissue-penetrating tipdistal of the hook-shaped distal portion; and a needle deploymentmechanism coupled to a proximal portion of the needle and disposed atleast partially within the elongate body member for actuating the needlebetween the first opening and the second opening.
 19. The suturinginstrument of claim 18 wherein the needle further comprises a latchmovable between a first position in which the hook-shaped distal portionis opened as the needle exits the first opening and a second position inwhich the hook-shaped distal portion is closed as the needle exits thesecond opening with the suture, thereby capturing the suture in thehook-shaped distal portion of the needle.